This invention relates to programmable transdermal therapeutic systems (PTTS) and to manufacturing programmable transdermal therapeutic systems (PTTS) or transdermal patches, which comprise drug reservoirs of highly stabilized supersaturated drug solid polymer solution and a controlled release membrane with an easily adjustable release rate.
After the marketing of transdermal therapeutic systems (TTS) since the 1980's, TTS have been developed rapidly, owing to certain advantages not provided by traditional methods of drug administration.
TTS can steadily control (one day to one week) an adequate constant release dose rate of drug into the systemic blood circulating system, without the presence of peaks and valleys in blood drug concentration, irritation of gastric and intestinal tracts, and the first-pass effect of liver.
TTS also can be used conveniently with high patient compliance. This is so since TTS having advanced technology of release rate by controlled membrane can administer drug with a pre-determined adequate release rate and with minimal influence based on the varying permeability of skin which occurs at different sites and in different patients. The following commercially available TTS belong to the type of membrane controlled TTS: Transderm-Nitro.TM. (nitroglycerin TTS); Transderm-Scop.TM. (scoplamine TTS); Estraderm.TM. (estradiol TTS); Catapres-TTS.TM. (clonidine TTS); Nicoderm.TM. (nicotine TTS).
The long acting (several days to one week) membrane controlled TTS with effective and steady drug administration (such as clonidine TTS) incorporate a clonidine saturated solid polymer solution in the presence of excess fine clonidine particles as drug reservoir (U.S. Pat. No. 4,201,211), to insure extended duration of drug saturated state that maintains a constant drug concentration and concentration gradient for a required constant zero order release rate of drug.
However, some symptoms require not only long acting duration of drug administration, but also a decreasing dosage rate which automatically corresponds to a schedule of decreased symptoms, i.e., an adequate pre-determined program of release dose rate of drug, to greatly relieve side effects. An example is clonidine (a non-opiate detoxification drug) therapy in opiate withdrawal syndrome.